Orally disintegration tablets are solid dosage forms containing active pharmaceutical ingredient which disintegrate rapidly usually less than 60 seconds without need a water when placed on the tongue. Ibuprofen, which is practically water insoluble, shows low bioavailability. One of technique that can solve this problem in ODTs formulation is lyophilization that can change the crystalline form of drug into amorf form. The aim of this study are determining the characteristics of ODTs product, the effect of formulation technique and excipients adding.
Ibuprofen ODTs were formulated by using water soluble matrix consisting gelatine 5% and mannitol in the ratio 0:200 (F1); 50:150 (F2); 100:100 (F3); 150:50 (F4); 200:0 (F5) in way poured mixture into each of the pockets of tablet blister (d = 13 mm) to contain weight 400 mg/tablet, then freezed in the freezer and placed frozen tablets in a freeze dryer to remove water. The resulting tablets were evaluated using parameters: hardness, friability, disintegration time using disintegration tester USP, disintegration time modified tester, disintegration time in the oral cavity, wetting time, water absorption, assay, dosage uniformity and dissolution.
The results showed that ibuprofen ODTs, were prepared by lyophilization process using a mixture of gelatine 5% and mannitol as matrix, fulfilled the requirements for active ingredient, dosage uniformity, hardness, friability, disintegration time using disintegration tester USP, disintegration time in the oral cavity and dissolution except for F5 formula didn’t produce physical shape intact tablet. ODTs using more amount of gelatine 5% showed faster disintegration time (19 s (F1); 29.2 s (F2); 36 s (F3) and 57.5 s (F4)). Inversely, more amount of mannitol used in ODTs formulas, higher tablet hardness was resulted. In vitro drug release of all formulation ODTs showed high drug release in the first minute where the F1 97.77%; F2 89.66%, 87.80% F3; F4 72.97%, much different with pure ibuprofen released only 27.15%. From ANOVA test using SPSS program 15.0 (p < 0,05) showed that presence of significant differences dissolution profiles between all ODTs formulas with pure ibuprofen.
Ibuprofen ODTs that were formulated by liophilization process, have fast disintegration time characteristics and optimal tablet hardness. Formulation process produces a changging the crystalline towards the amorphous form. Gelatine 5% acts as a binder and a disintegrant while mannitol affects the ODT hardness.